KLS-MARTIN RIGID EXTERNAL DISTRACTION DEVICE

K972047 · KLS-Martin L.P. · MQN · Jun 24, 1997 · Dental

Device Facts

• Record ID: K972047
• Device Name: KLS-MARTIN RIGID EXTERNAL DISTRACTION DEVICE
• Applicant: KLS-Martin L.P.
• Product Code: MQN · Dental
• Decision Date: Jun 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KLS-Martin Rigid External Distraction (RED) device is utilized for the purpose of maxillary and midface osteodistraction in the reconstruction of patients with congenital and acquired craniofacial anomalies.

Device Story

The KLS-Martin Rigid External Distraction (RED) device is a mechanical system used for maxillary and midface osteodistraction. It is intended for the reconstruction of patients with congenital and acquired craniofacial anomalies. The device is applied externally to provide the necessary distraction forces to the craniofacial skeleton. It is operated by a physician in a clinical or surgical setting. The device facilitates bone growth and structural correction through controlled distraction, aiding in the reconstruction of complex craniofacial deformities.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Rigid external distraction device; mechanical system for osteodistraction; external application.

Indications for Use

Indicated for maxillary and midface osteodistraction in patients with congenital and acquired craniofacial anomalies requiring reconstruction.

Regulatory Classification

Identification

A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three heads, representing the department's focus on health, human services, and the well-being of the population. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

:

## JUN 24 1997

Mr. Ed Ransom KLS-Martin C/O Regulatory & Marketing Services, Incorporated 40178 U.S. 19 North Tarpon Springs, Florida 34689

Re : K972047 KLS-Martin Rigid External Distraction Device Trade Name: Requlatory Class: II Product Code: MQN Dated: May 28, 1997 Received: June 2, 1997

Dear Mr. Ransom:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, qood manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Ransom

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 5.0(k) premarket notification. The FDA ... . finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours,

Patricia Crescent /for

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health '

Enclosure

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510(k) Number (if known): _______

______________________________________________________________________________________________________________________________________________________________________________ Device Name:

Indications For Use:

The KLS-Martin Rigid External Distraction (RED) device is utilized for the purpose of maxillary and midface osteodistraction in the reconstruction of patients with congenital and acquired craniofacial anomalies.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Russoe

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Dr 510(k) Number

Prescription Use 1 (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)